- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07565714
Optimization of Late Imagery Rescripting Research Using Generative Artificial Intelligence (ImRs_LLM_DeanG)
The aim of the study is to examine the effect of imagery rescripting (ImRs) in the context of utilizing large language models (LLMs). Intervention will involve the prior presentation of the most aversive fragment of the memory, the so-called 'hotspot.' This intervention will allow for the replication of the effect described by Dibbets and Arntz (2016), according to which the prior activation of the most emotional element of a memory enhances the effectiveness of ImRs.
The study is also significant due to another ongoing study in which a substantial number of participants have already been examined; however, due to the exhaustion of funds, it was not possible to utilize the remainder of the recruited sample. Investigating an additional condition will allow for a more complete utilization of the available participant pool and significantly increase the project's scientific value by comparing the traditional ImRs mechanism with its AI-generated version.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This pilot randomized controlled trial will explore the application of large language models (LLMs) in the development of personalized therapeutic interventions. The study will focus on the emotional and psychophysiological effects of listening to autobiographical scenarios based on participants' childhood experiences of parental criticism. All participants will be asked to recall and describe two critical and two neutral childhood memories. Based on this input, personalized scripts will be generated using Gemini, a large language model. Each script will be reviewed and, if necessary, modified by trained experimenters to ensure therapeutic coherence and alignment with imagery rescripting (ImRs) principles. On Day 1, all participants will listen to critical personalized scenarios during the laboratory session. The experimental group will listen to modified versions of the critical memory scripts, in which a therapist figure will intervene to address the child's unmet needs-an application of imagery rescripting. To assess physiological arousal, skin conductance will be continuously recorded throughout the session. After each scenario, participants will rate their emotional intensity and specific feelings (e.g., fear, sadness) on Likert scales. The group will receive the ImRs intervention after the initial scenario phase. One week later, all participants will complete follow-up questionnaires assessing generalized anxiety (GAD-7) and the frequency of intrusive thoughts related to the memories. In addition, a panel of licensed cognitive-behavioral therapists will evaluate the generated scenarios for therapeutic quality. Their feedback will be used to assess the acceptability and coherence of AI-assisted therapeutic scripts. The study will test the feasibility of using LLM-generated content in clinical settings and aims to determine whether such interventions can reduce distress and intrusiveness while eliciting measurable emotional and physiological responses
Hypotheses:
The criticism scenarios generated by the model will elicit fearful responses in all participants.
The level of fearful reaction evoked by the AI-generated criticism scenarios will correlate with participants' baseline fear of failure.
Participants in the ImRs group will report fewer intrusive thoughts and lower generalized anxiety levels one week after the intervention.
Magnitude of Prediction Error (operationalized as a difference in SCL response between hotspot and intervention parts of the scenario) will correlate positively with a decrease in the number of intrusive thoughts.
The magnitude of imagery difficulty during the rescripting part will correlate negatively with the magnitude of Prediction Error.
Subjective efficacy of intervention will be predicted by working alliance.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stanisław Karkosz, MA
- Phone Number: +48 570 668 996
- Email: skarkosz@swps.edu.pl
Study Locations
-
-
Wielkopolska
-
Poznan, Wielkopolska, Poland, 61-619
- Recruiting
- SWPS University (University of Social Sciences and Humanities); Poznań Laboratory of Affective Neuroscience
-
Contact:
- Stanisław Karkosz, MA
- Phone Number: +48 +48 570 668 996
- Email: skarkosz@swps.edu.pl
-
Poznan, Wielkopolska, Poland, 61-619
- Recruiting
- SWPS University of Social Sciences and Humanities; Poznań Laboratory of Affective Neuroscience
-
Contact:
- Stanisław Karkosz, MA
- Email: skarkosz@swps.edu.pl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18-35
- Score ≥ 8 on GAD-7 (Plummer et al., 2016)
- Ability to recall at least two childhood memories involving parental criticism
Exclusion Criteria:
- History of prolonged physical or sexual abuse
- Current psychotherapy or psychopharmacology
- PTSD diagnosis (DSM-5 screening)
- Substance abuse (TAPS tool)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ImRs AI
Participants listened to personalized audio scripts based on their own childhood memories of parental criticism and neutral events.
All participants heard both critical and neutral scenarios.
At the end of the session, one critical scenario was presented in a modified version that included an imagery rescripting (ImRs) intervention, in which a therapist figure entered the imagined scene and addressed the child's unmet needs.
All scripts were generated by the Gemini large language model and reviewed by experimenters.
Participants rated their emotional responses and underwent continuous skin conductance recording during the session.
Follow-up assessments were conducted one week later.
(?)
|
Participants listened to a series of personalized audio scenarios based on their childhood memories of parental criticism and neutral events.
At the end of the session, one critical scenario was presented in a modified version that included a therapeutic imagery rescripting (ImRs) intervention.
In this script, a therapist figure entered the scene and addressed the child's unmet needs, following the standard rescripting format.
The scripts were generated using the Gemini large language model and reviewed by trained experimenters to ensure coherence and therapeutic validity.
The intervention aimed to reduce distress and intrusive thoughts related to the memory.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Performance Failure Appraisal Inventory
Time Frame: Pre-intervention (Day 1)
|
The Performance Failure Appraisal Inventory was used to assess fear of failure.
It is a 25-item questionnaire that measures the strength of subjective beliefs about the consequences of failure.
The PFAI has five subscales: fear of experiencing shame and embarrassment; fear of devaluing one's self-esteem; fear of having an uncertain future; fear of important others losing interest; and fear of upsetting important others.
PFAI score ranges from 35 to 175, with higher scores indicating a higher level of fear of failure.
|
Pre-intervention (Day 1)
|
|
Intrusive Thought Frequency (Rumination Inventory - adapted)
Time Frame: Pre-intervention (Day 1) and 1-week follow-up
|
A modified version of the Event-Related Rumination Inventory will be used to assess the frequency and intrusiveness of thoughts related to the autobiographical criticism memories.
The scale includes both intrusive and reflective rumination items, ranging from 20 to 80, with higher scores indicating a higher level of event-related rumination.
Change in scores between baseline and follow-up will serve as an index of the cognitive impact of the intervention.
|
Pre-intervention (Day 1) and 1-week follow-up
|
|
Skin Conductance Level (SCL)
Time Frame: During experiment/intervention (Day 1)
|
Electrodermal activity will be recorded continuously during the presentation of autobiographical scenarios to assess physiological arousal.
The SCL signal will be analyzed during the baseline, critical, and neutral conditions, as well as during the imagery rescripting (ImRs) intervention (experimental group only).
Data will be used to examine whether AI-generated criticism scripts elicit arousal.
|
During experiment/intervention (Day 1)
|
|
Emotional Response Ratings (Subjective)
Time Frame: During experiment/intervention (Day 1)
|
Participants will rate the intensity of emotional reactions (fear, sadness, arousal, etc.) using Likert scales after each presented scenario.
Scores will range from 1 to 10, with higher scores indicating a more intense emotional reaction.
These ratings will help determine emotional engagement and compare affective response between criticism and neutral content, as well as between groups.
|
During experiment/intervention (Day 1)
|
|
Generalized Anxiety Disorder DSM Scale (GAD)
Time Frame: Screening, Pre-intervention (Day 1) and 1-week follow-up
|
DSM Scale (Craske et al., 2013, own translation); brief dimensional self-rating questionnaire for generalized anxiety disorder (American Psychiatric Association, 2013, Polish translation: translation made by the authors using a standard back-translation method, 2020).
Scale consists of 10 items relating to the thoughts, feelings, and behaviors the subjects have experienced in the last 7 days.
The answers are marked on a 4-point Likert scale (0=never, 4=all the time), with scores ranging 0-4.
|
Screening, Pre-intervention (Day 1) and 1-week follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Therapist Ratings of Script Quality
Time Frame: Prior to intervention
|
A panel of cognitive-behavioral therapists will rate the AI-generated and manually created scripts on a 10-point Likert scale ranging from 1 to 20, for therapeutic quality, coherence, and emotional relevance.
Higher scores will indicate higher quality/coherence/emotional relevance.
Average therapist ratings will be used to test hypotheses about the acceptability of LLM-generated therapeutic content.
|
Prior to intervention
|
|
Questionnaire on the Perceived Effectiveness and Appropriateness of Imagery-Based Intervention
Time Frame: Post-intervention (Day 1)
|
A custom-developed questionnaire will be administered to participants in the experimental group to assess their subjective evaluation of the imagery rescripting intervention.
The measure includes items evaluating emotional intensity, difficulty with imagery, resistance to memory modification, trust in the therapeutic process, realism of the experience, and other affective and cognitive responses.
Items are rated on 5-point Likert scales and grouped into subscales representing common therapeutic barriers and facilitators.
Each subscale ranges from 4 to 20, with a higher score indicating a higher problem with imagery techniques.
The total and subscale scores will be analyzed to explore which factors are associated with intervention acceptance and perceived effectiveness.
|
Post-intervention (Day 1)
|
|
TAPS Tool - Substance Use Screening
Time Frame: Screening only
|
The Tobacco, Alcohol, Prescription Medication, and Other Substance Use Tool (TAPS) will be used to screen for problematic substance use.
The self-report version of the TAPS consists of two parts: (1) past 12-month use of tobacco, alcohol, illicit drugs, and prescription medication for non-medical use.
Scores will range from 1 (never) to 5 (every day/almost every day), with higher scores indicating a greater frequency of substance use.
Scores will be used to exclude participants with probable substance use disorders, in line with the study's eligibility criteria.
|
Screening only
|
|
Post-Traumatic Stress Symptoms Scale (DSM)
Time Frame: Screening only
|
Self-report scale assessing PTSD symptoms as defined by DSM-5 criteria.
The instrument includes 10 items evaluating symptom frequency over the previous 7 days on a 0-4 Likert scale.
Total scores range from 0 to 40.
|
Screening only
|
|
Working Alliance Inventory - Short Revised
Time Frame: Post-intervention (Day 1)
|
The Working Alliance Inventory - Short Revised (WAI-SR) is a 12-item self-report measure assessing the perceived quality of the therapeutic alliance across three subscales: Goal, Task, and Bond.
Each subscale ranges from 4 to 20, with a higher score indicating a higher level of working alliance factors.
General scores range from 12 to 60, with a higher score indicating a higher level of working alliance.
In this study, the WAI-SR was adapted to assess participants' sense of connection and alliance with the AI-delivered intervention (e.g., the rescripting script and voice used).
Scores will be used to explore whether the subjective sense of alliance predicts perceived effectiveness, emotional impact, or response to the intervention.
|
Post-intervention (Day 1)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beck Depression Inventory
Time Frame: Screening only
|
The Beck Depression Inventory, Second Edition (BDI-II), is a 21-item self-report questionnaire assessing the severity of depressive symptoms, with total scores ranging from 0 to 63.
Higher scores indicate higher levels of depressive symptoms.
In this study, the BDI-II was administered at screening to assess baseline depressive symptoms.
While not used as a formal outcome variable, BDI-II scores may be included in exploratory analyses to examine their potential moderating effects on emotional responses or intervention acceptance.
|
Screening only
|
Collaborators and Investigators
Investigators
- Principal Investigator: Stanisław Karkosz, MA, SWPS University
Publications and helpful links
General Publications
- Yao, Y., Duan, J., Xu, K., Cai, Y., Sun, Z., & Zhang, Y. (2024). A survey on large language model (llm) security and privacy: The good, the bad, and the ugly. High-Confidence Computing, 100211
- Conroy, D. E. (2001). Progress in the development of a multidimensional measure of fear of failure: The Performance Failure Appraisal Inventory (PFAI). Anxiety, Stress and Coping, 14(4), 431-452.
- Arntz, A. (2012). Imagery rescripting as a therapeutic technique: Review of clinical trials, basic studies, and research agenda. Journal of Experimental Psychopathology, 3(2), 189-208.
- Bradley MM, Sambuco N, Lang PJ. Imagery, emotion, and bioinformational theory: From body to brain. Biol Psychol. 2023 Oct;183:108669. doi: 10.1016/j.biopsycho.2023.108669. Epub 2023 Aug 28.
- McNeely J, Wu LT, Subramaniam G, Sharma G, Cathers LA, Svikis D, Sleiter L, Russell L, Nordeck C, Sharma A, O'Grady KE, Bouk LB, Cushing C, King J, Wahle A, Schwartz RP. Performance of the Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS) Tool for Substance Use Screening in Primary Care Patients. Ann Intern Med. 2016 Nov 15;165(10):690-699. doi: 10.7326/M16-0317. Epub 2016 Sep 6.
- Mossman SA, Luft MJ, Schroeder HK, Varney ST, Fleck DE, Barzman DH, Gilman R, DelBello MP, Strawn JR. The Generalized Anxiety Disorder 7-item scale in adolescents with generalized anxiety disorder: Signal detection and validation. Ann Clin Psychiatry. 2017 Nov;29(4):227-234A.
- Busseri MA, Tyler JD. Interchangeability of the Working Alliance Inventory and Working Alliance Inventory, Short Form. Psychol Assess. 2003 Jun;15(2):193-7. doi: 10.1037/1040-3590.15.2.193.</citation> <pubmed_id>12847779
- Cann A, Calhoun LG, Tedeschi RG, Triplett KN, Vishnevsky T, Lindstrom CM. Assessing posttraumatic cognitive processes: the Event Related Rumination Inventory. Anxiety Stress Coping. 2011 Mar;24(2):137-56. doi: 10.1080/10615806.2010.529901.</citation> <pubmed_id>21082446
- Dibbets P, Arntz A. Imagery rescripting: Is incorporation of the most aversive scenes necessary? Memory. 2016;24(5):683-95. doi: 10.1080/09658211.2015.1043307. Epub 2015 Jun 15.
- LeBeau R, Mischel E, Resnick H, Kilpatrick D, Friedman M, Craske M. Dimensional assessment of posttraumatic stress disorder in DSM-5. Psychiatry Res. 2014 Aug 15;218(1-2):143-7. doi: 10.1016/j.psychres.2014.03.032. Epub 2014 Apr 5.
- Leyton F, Olhaberry M, Moran J, De la Cerda C, Leon MJ, Sieverson C, Alfaro A, Hernandez C, Alvardo R, Steele H. Video Intervention Therapy for primary caregivers in a child psychiatry unit: a randomized feasibility trial. Trials. 2021 Oct 30;22(1):754. doi: 10.1186/s13063-021-05668-w.
- Plummer F, Manea L, Trepel D, McMillan D. Screening for anxiety disorders with the GAD-7 and GAD-2: a systematic review and diagnostic metaanalysis. Gen Hosp Psychiatry. 2016 Mar-Apr;39:24-31. doi: 10.1016/j.genhosppsych.2015.11.005. Epub 2015 Nov 18.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ImRs_LLM_DeanGrant
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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